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GS-9137- A Novel HIV-1 Integrase Inhibitor

Phase 2

HIV | Small molecule | Infectious Disease |Gilead Sciences, Inc.|Last Updated: Jul 29, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLEDDMC
Total Trials1
Total Enrollment278

FDA Designations

No designations recorded

Clinical trial landscape

GS-9137- A Novel HIV-1 Integrase Inhibitor · 1 trial · 3 indications

Phase 2 1
NCT00298350Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.HIV
COMPLETED278 Analytics
PHASE2COMPLETED
Ritonavir-Boosted GS-9137 vs. Ritonavir-Boosted Protease Inhibitor(s) in Combination With Background ART.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
GS-9137 - A Novel HIV-1 Integrase InhibitorDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites54

Inclusion Criteria: * HIV RNA greater than or equal to 1000 c/mL. * Failed/Failing protease inhibitor based antiretroviral therapy. * Stable antiretroviral therapy for greater than or equal to 30 days prior to screening. * Negative Serum Pregnancy Test. * GFR by Cockcroft Gault greater than or equa...

Countries:United StatesPuerto Rico
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Frequently asked questions about GS-9137- A Novel HIV-1 Integrase Inhibitor

What is GS-9137 used for?

GS-9137 is an investigational small molecule being developed for the treatment of HIV, including HIV-1 and human immunodeficiency virus infections. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does GS-9137 target?

GS-9137 is a novel HIV-1 integrase inhibitor. It works by targeting the integrase enzyme, which is essential for HIV replication, thereby potentially blocking the virus from integrating into host cells.

Who makes GS-9137?

GS-9137 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in HIV patients.

What phase is GS-9137 in?

GS-9137 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory bodies for commercial use.

What clinical trials is GS-9137 in?

GS-9137 has one completed Phase 2 clinical trial, identified as NCT00298350. This study evaluated ritonavir-boosted GS-9137 versus ritonavir-boosted protease inhibitors in combination with background antiretroviral therapy in 278 participants with HIV.

Is GS-9137 the same as elvitegravir?

GS-9137 is also known as elvitegravir, an HIV-1 integrase inhibitor. This alternative name is used in clinical and research contexts to refer to the same investigational drug developed by Gilead Sciences.